Clinical trials: Feeding, Breast
Breast Milk Expression
Effect of Consuming a Combination of Probiotic Strains and a Combination of Plant Extracts and a Probiotic Strain on the Production and Nutritional Composition of Breast Milk
The objective of this trial is to evaluate the effect of the consumption of a combination of probiotic strains (Prob-milk) and of a combination of plant extracts plus an inactivated probiotic strain (VoluntasProb) on the…
- Trial name
- NCT04639232
- Testing
- Prob-milk, Voluntas-Prob
- Where
- Spain
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
Mastitis, Breast Milk
Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis
The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis.
- Conditions
- Mastitis, Breast Milk, Lactation, Women's Health
- Trial name
- NCT04032899
- Testing
- Lactobacillus fermentum CECT5716, Maltodextrin
- Where
- 3 sites in Spain
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration…
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease
- Trial name
- CRADLE (NCT02154425)
- Testing
- Breast milk sampling, Certolizumab Pegol
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 17 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Breastfeeding
Pilot Study of the FEEDBACK System for Use With Infants in the Neonatal Intensive Care Unit at University of Virginia
The purpose of this study is to assess the accuracy of FEEDBACK for measuring breastmilk intake of a pre-term baby. Mothers and babies will use the FEEDBACK system during a breastfeeding session in the NICU.
- Trial name
- NCT03702686
- Testing
- FEEDBACK System
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Molex Ventures LLC
Breast Fed Infants
Plasma Profile of Exclusively Breastfed Infants
To characterize nutrient levels in breastfeeding infants and their mothers.
- Trial name
- NCT01669655
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Breast Pumping
Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card
The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.
- Trial name
- Initiate (NCT04619212)
- Testing
- breast pumping as per SoC but on new software for the pump
- Where
- Netherlands
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Medela AG
Healthy Infants
Comparative Effects of A2 Platinum Stage 1 Infant Formula on Infant Digestion and Comfort
This trial is a single-blind, randomized, controlled, parallel-designed trial to compare the effects of a2 Platinum® stage 1 infant formula versus conventional, A1 and A2 β-casein-containing stage 1 infant formula versus…
- Trial name
- NCT04733937
- Testing
- a2 Platinum® stage 1 infant formula, Conventional, A1 and A2 β-casein containing stage 1 infant formula
- Where
- 5 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
Breast Feeding, Milk, Human
A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
The current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers and their newborns will make it possible to explore human milk composition across different lactation stages, between different human milk…
- Trial name
- NCT05979532
- Where
- Netherlands
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Breast Milk Collection
Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet
The study will collect human milk from 100 mother of term infants 2-3m after delivery and from 50 mothers of preterm infants 14 and 30 days after delivery.
- Trial name
- NCT02596295
- Where
- Israel
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Breastmilk Collection
Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
Exclusive breastfeeding during the first six months of life and continued breastfeeding for at least 24 months constitute the optimal feeding method for infants and young children.
- Trial name
- BREASTMILKVIR (NCT06738563)
- Testing
- Collection breast milk
- Where
- France
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Breast Feeding, Constipation
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women…
- Conditions
- Breast Feeding, Constipation, Irritable Bowel Syndrome
- Trial name
- LIN-PK-01 (NCT02220348)
- Testing
- linaclotide
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Forest Laboratories
Lactation
An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females
This is an open label study to investigate PK of tenapanor and AZ13792925 in breast milk of lactating female subjects.
- Trial name
- NCT06203444
- Testing
- Tenapanor
- Where
- 2 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Ardelyx
Breast Pumping
Evaluation of Fluid-Filled Expression Core Technology Study - I
A functional model of a fluid-filled, smaller dead volume breast pump has been developed in order to more closely mimic the breastfeeding infant.
- Trial name
- Effect-1 (NCT03921918)
- Testing
- Breast Pump
- Where
- Switzerland
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Medela AG
Pregnancy Related
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12…
- Trial name
- NCT06258902
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ipsen
Diarrhea, Acute Respiratory Infection
Oral Supplement for Pregnant and Lactating Mothers
To assess protection against early life infections through supplementation of mothers during pregnancy to the newborns' growth, morbidity, immune status intra and extra-uterine.
- Trial name
- NCT01073033
- Testing
- milk supplement 1, milk supplement 2
- Where
- Philippines
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Breastfeeding, Exclusive Breastfeeding
KULEA-NET: A Mobile Application for African American/Black Mothers to Promote Exclusive and Continuous Breastfeeding
KULEA-NET is a mHealth intervention that will improve knowledge, self-efficacy, and intentions related to exclusive breastfeeding (EBF).
- Trial name
- KULEA-NET (NCT05985876)
- Testing
- KULEA-NET application, Control Group: Usual Care
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Benten Technologies, Inc.
Healthy
A Study to Learn How the Study Medicine Called Zavegepant is Taken Up Into Blood and Breast Milk of Healthy Breast-Feeding Women
The purpose of the study is to look at the amount of zavegepant that is present in breast milk after single dose of zavegepant is sprayed through the nose in healthy breast-feeding women.
- Trial name
- NCT06453356
- Testing
- Zavegepant 10mg
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Anemia, Pregnancy
Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia
The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered…
- Conditions
- Renal Anemia, Pregnancy, Lactation
- Trial name
- PASCO II (NCT01543477)
- Where
- 179 sites in Bulgaria, Croatia and 10 more
- Volunteers
- 4,501 people
- Sponsor
- Pfizer
Weaning
Impact of a Fermented Infant Formula in Weaning Babies
When mothers wanted to shift from breast milk to infant formulae, babies were randomly assigned to receive a fermented or a standard formula.
- Trial name
- NCT00858026
- Testing
- Breastmilk, Standard milk, Fermented milk
- Where
- 6 sites in France
- Volunteers
- 91 people
- Sponsor
- Bledina
Lactation
Lactation Fortification Study
To investigate the impact of nutrient supplementation during lactation on levels in breast milk.
- Trial name
- NCT01747668
- Testing
- Similac Prenatal Vitamin soft-gel capsule
- Where
- 6 sites in United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition